# FDA recall Z-1928-2021

> **Quidel Corporation** · Class I · device recall initiated 2021-04-27.

## Product

Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

## Reason for recall

In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5  from Lyra SARS-CoV-2 Assay users.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.

## Key facts

- **Recall number:** Z-1928-2021
- **Recalling firm:** Quidel Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-27
- **Report date:** 2021-07-07
- **Termination date:** 2022-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1928-2021

## Citation

> AI Analytics. FDA recall Z-1928-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1928-2021. Source: US FDA. Licensed CC0.

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